Quality Assurance and Quality Control
Learn about quality assurance and quality control, understand their differences in application, and how good QA and QC practices can benefit your business
Learn about quality assurance and quality control, understand their differences in application, and how good QA and QC practices can benefit your business
Quality assurance (commonly referred to as QA) is a set of principles, processes, and protocols a company sets in order to ensure that the quality of the products and services they offer are consistently high and are compliant with organizational and regulatory standards.
Once the model for high quality has been set, QA steps in to serve as a template to guide workers in meeting quality objectives for each individual product and for each instance a service is rendered.
“Quality is everyone’s responsibility.” – W. Edwards Deming engineer, statistician, professor, author, and lecturer
We all have our own ideas on what quality is supposed to be. But in the context of the products and services we pay for, the work we do, and the life we live, we all want and strive for good quality.
People can be thrifty, but most of us are willing to pay top dollar for what we judge to be of good quality. This is the reason why successful companies go to great lengths and spend a considerable amount of time and resources to provide good quality. Achieving, ensuring, and maintaining good quality, however, are different disciplines.
Products of good quality create demand, meeting demand generates profit, and profit is used to create supply and meet demand. This is the cycle of success which starts when a company achieves, ensures, and maintains good quality.
Where QA concerns itself with the process, quality control (or QC) is the inspection of a finished product to evaluate whether it passes quality standards before it is shipped out to consumers.
QC adds an extra line of security against defective products and bad service, and it also provides valuable data when assessing the effectiveness of your QA process.
Good quality assurance and quality control are two of the most important elements of a successful operation. Achieving, ensuring, and maintaining the quality of your goods and services are paramount to making your customers happy and keep them coming back.
Origins, regulations, techniques, and principles
I.Pioneers of Quality
In the middle ages, manufacturing and commerce enjoyed a period of growth that helped artisans gain prominence as valued craftsmen. Guilds became an important factor in this period’s product and service quality, similar to today’s ISO.
A guild is an association by the workers, for the workers. Typically, each territory would have their own merchant guild (sellers of goods and services), and craft guild (blacksmiths, masons, bakers, haberdashers, and other workers that serve the essentials of daily living). Guilds screened applicants and shouldered the apprenticeship costs of new members. Aside from training guild members in the industry’s best practices, guilds also performed inspections to ensure that the products and services of their members complied with the accepted standards at the time.
The next significant period in the development of QA and QC was the First Industrial Revolution. According to Prof. Christoph Roser, it began in 1715, when the Englishman John Lombe went to Italy to copy an Italian design for a mechanized silk loom. In subsequent years, division of labor was put into practice. This made the entire production process more efficient and improved quality assurance because it allowed workers and machines to focus on a single task.
In the early 19th century, Americans Frederick Winslow Taylor and Henry Ford advocated industrial efficiency, with the latter becoming famous for developing the assembly line as a method of mass production.
ISO stands for International Organization for Standardization. It is an independent organization currently composed of 164 countries and is the world’s leading authority and regulating body for safety and quality standards in manufacturing and service.
ISO Standards are specific criteria set by ISO covering different aspects of business operations. By applying for and passing an ISO audit for a certain standard, a company earns a coveted ISO Certification. Having an ISO Certification boosts your company’s trustworthiness in the eyes of prospective clients and gives you a considerable competitive advantage over rivals who have yet to acquire theirs.
To date, ISO boasts almost 22,000 standards and certifications covering a wide variety of operational aspects. Below are some of the most common standards companies strive for:
Last updated in 2015, ISO 9001:2015 specifies the requirements for a company’s QMS (Quality Management System). It aims to assess an operation’s ability to consistently deliver high-quality products and services while meeting customer expectations and relevant statutory and regulatory requirements.
ISO 22000 provides requirements for developing and implementing a Food Safety Management System (FSMS). This certification is a must-have for companies in the food processing and food service industries.
Another popular ISO standard, ISO 27001 is concerned with a company’s ability to implement an effective Information Security Management System (ISMS) in order to keep confidential business information safe from unauthorized access.
The ISO 31000 certification sets the standard for frameworking, designing, implementing, and maintaining a risk management system on a company-wide level.
Last updated in 2018, ISO 45001 sets the international standard for Occupational Health & Safety (OH&S) Management Systems. Failure to comply can lead to workplace accidents and diseases, lawsuits, and cost overruns.
Modern manufacturing SOPs may vary depending on the industry, nature of the business, and brand. What highly successful corporations have in common, however, is their embodiment of the tried and tested QA techniques and principles listed below.
Motorola pioneered the use of Six Sigma in the mid-80’s, which several companies in a wide variety of industries have since adapted as a standard business practice. Six Sigma is a problem-solving technique that aims to reduce defects and manage variations from set internal specifications. The term “Sigma” in statistics, pertains to the standard deviation from the mean or average of a process data set. As a concrete example, a process needs to have a maximum of only 3.4 defects per one million opportunities to be considered of “Six Sigma Quality.”
Six Sigma aims to accomplish three things:
In order to obtain Six Sigma certification, management must first determine if they’re trying to improve an existing product or process or creating a new one.
DMAIC (Define, Measure, Analyze, Improve, Control)
The DMAIC methodology is used to improve existing processes that fail to achieve set goals:
Define customer needs and expected results.
Measure relevant empirical data such as current performance.
Analyze available data and do a root-cause analysis to accurately identify the real problem instead of its symptoms.
Improve the current process by conceptualizing solutions from the expected output, current performance, and identified root cause.
Control new process to avoid deviations beyond standard limits. This step may be done as many times as needed until the process has been optimized to meet project goals.
DMADV (Define, Measure, Analyze, Design, Verify)
By contrast, the DMADV methodology is used to come up with new processes or products of Six Sigma Quality:
Define goals for product design and functionality based on customer needs and organization’s identity.
Measure the viability of ideal production rate, product capabilities, and possible failures.
Analyze objectives to develop optimal design.
Design a product/service based on the available information.
Verify design through testing.
Lean, or Lean Manufacturing, is a management philosophy popularized by Toyota. Other companies later adapted it after Toyota rose to prominence as one of the top auto manufacturers in the world.
Its primary focus is to identify and eliminate “waste” in the production process in order to improve overall efficiency. This pertains to steps and/or arrangements that are deemed, after logical analysis, unnecessary and should be discontinued. More specifically, Lean aims to identify the presence of and eliminate the “Seven Deadly Wastes” detailed below:
Though numerous companies apply Lean principles to their operations, their methodology and tools of choice may vary. Below are some of the most widely used tools companies use to practice Lean:
Seiri (Sort), Seiton (Set in Order), Seiso (Shine), Seiketsu (Standardize), and Shitsuke (Sustain) are the processes involved in 5S. This system focuses on organizing the workplace, ensuring that items, equipment, documents, and other workplace staples are in their proper places so that work performance can improve organically through management and safety.
The purpose of the first step is to ensure that:
Seiton (Set in Order)
The purpose of the second step is to ensure that:
The purpose of the third step is to ensure that:
The purpose of the fourth step is to ensure that:
The purpose of the fifth step is to ensure that:
With proper utilization and consistent practice, companies benefit from 5S through reduced costs, improved efficiency, and a safer working space.
PDCA Problem Solving
Another staple in Toyota’s business process is the A3 Report, dubbed as such for it being a one-page report usually printed on A3-size papers. The A3 Report utilizes Deming’s PDCA/PDSA Problem Solving Method to identify, eradicate, and prevent recurrence of problems in operation.
Toyota pioneered multiple manufacturing and management models that have become business standards in several organizations, and 5 Whys is no exception. This Lean technique is used by team managers to identify the root cause of a problem by asking “why” five times until it is discovered.
Here’s an example of 5 Whys in action:
Problem – The team failed to meet last month’s sales quota
Root-cause – There is no process for assigning who is in charge of monitoring materials
Kaizen is a Japanese term that means “change for good,” but is more loosely translated in the west as “continuous improvement.” What makes it different from other process improvement methods is that it aims to involve the entire organization, from top management to the assembly line workers, in its implementation. Having a Kaizen Culture in your organization means each individual, regardless of rank, is empowered to look for opportunities to improve every day, no matter how small.
Listed below are some of the most common Kaizen implementation tools used by companies:
SIPOC is a mapping tool that stands for Suppliers, Inputs, Process, Output, and Customers. It’s primary objective is to ensure clarity in process workflows. By doing so, unnecessary activities can be discontinued, accountability becomes clear, and the overall process is optimized for efficiency.
Performing a gemba walk means that executives, on a regular basis, will walk around the actual space where the work is being done (be it the production floor of a call center or a manufacturing plant) in order to observe objectively, understand the process, ask questions, and identify opportunities for improvement. Its goal is to ensure that upper management learns how things are actually done, instead of simply commenting on and reviewing individual work performance.
The 8D Report or the Eight Disciplines Model is a problem-solving technique used to contain, resolve, or prevent issues identified in a product or process by quality engineers and other responsible personnel. Initially only used by the automotive industry due to Ford’s influence, it is now widely used in a variety of industries, including manufacturing, healthcare, and retail, with great success.The 8D Report is a comprehensive method that aims to eliminate problems by identifying and attacking its root cause(s). It achieves this by utilizing a combination of expertise, data analysis, management tools, and data validation.
To come up with a great product or service, management can’t just sit back and let the business take care of itself. A truly successful and sustainable operation has an effective QA/QC strategy to keep product and service quality consistently high across all stores, branches, and service centers.
Build a Dedicated Quality Team
Having a dedicated QA/QC Team composed of personnel with the proper credentials should be a priority. Even in start-ups, where funding is limited and time-frames are shorter, a good quality team can help your operation meet or even exceed performance goals.
Before creating a team, consider the employee’s knowledge of your specific product/service along with prior experience in the same industry before they joined your company. Often, top performers are screened for the QA role because they have a good understanding of what makes the product/service work and what customers want, so that supply and demand can be reconciled. Being a top performer is also a good indication of an individual’s diligence towards their work, something the quality team is expected to exercise at all times.
Define Your Performance Goal
It may sound like a no-brainer, but plenty of Quality Teams, especially when starting out without a tested template to follow, make the elementary mistake of NOT clearly defining what success means for their product or service.
Quality Teams must consider the current performance of their product and/or service, define a SMART goal, and then strive to eliminate all of the processes, steps, and obstacles that do not contribute to the achievement of said goal.
Pick the Appropriate Quality Tool/Model for the Job
There is a plethora of QA and QC techniques, tools, and models available today. Though Kaizen, Six Sigma, and Lean offer generally applicable principles on improving quality, the right tools must be used to implement them in order to maximize their effectiveness.
A high standard for quality assurance and quality control makes all the difference between established global brands, and struggling businesses. The entire organization, from top management to the frontline workers, need to be immersed in a culture of quality and safety in order to do their best work.
Listed below are use cases for QA and QC templates covering different aspects of an operation. Utilizing the right template for the right job can help boost efficiency, prevent downtime, and ensure worker safety.
Operational Readiness Checklists
An operational readiness checklist is a structured project assessment tool that outlines the processes that must be taken before work commences. Using an operational readiness checklist can help ensure that the correct safety and mandatory measures have been taken care of so operations can proceed without a hitch.
Commissioning checklists are used in the process of verifying the performance of facilities, systems, and assemblies to ensure trouble-free outcomes and mitigate the risk of unplanned outages. Project managers, contractors, and construction engineers also perform pre-commissioning to confirm that equipment installation and function follows client specifications.
Vendor Risk Assessment
A vendor risk assessment is the process of screening and evaluating third party suppliers as potential business partners. It aims to identify risks and hazards associated with the vendor’s processes and products and determine if they are fit and qualified with the requirements set by the organization.
Process Validation Report
A process validation report provides proper documentation of qualification protocols, such as equipment qualification, installation qualification, operational qualification, and performance qualification, as evidence that a manufacturing process is capable of consistently delivering quality products. Quality assurance managers in the pharmaceutical manufacturing industry use a process validation report template to ensure compliance with US Food and Drug Administration (FDA) regulations, especially before the routine commercial production for a new formula or within a new facility and when well-established processes have not undergone a formally documented validation.
Production Part Approval Process (PPAP) is an 18-step guideline for Original Equipment Manufacturers (OEMs) and suppliers. Manufacturing plant managers can use PPAP checklists to show that OEMs and suppliers understand customer specifications and ensure that their manufacturing process consistently produces conforming parts at the quoted production rate. Customers examine the PPAP documents and determine the production part approval process status—fully approved, interim approval, or rejected.
Advanced Product Quality Planning (APQP) is a structured process employed when introducing a new product in the market or incorporating changes in the product after its release. A Cross-Functional Team (CFT) composed of engineering, manufacturing, quality, procurement, and distribution professionals can use an APQP checklist to ensure that products meet or even exceed customer requirements.
A First Article Inspection (FAI) is the process of verifying the design requirements of a product from the first production run. Quality inspectors can use FAI forms when there is a 2-year lapse in production or when there are significant changes in the product, including design, manufacturing source/process, location of manufacture, tooling/materials, or computer-generated program that can affect its fit, form, or function.
IATF Audit Checklists
An IATF audit is the process of evaluating if an automotive manufacturer’s Quality Management System (QMS) aligns with the IATF 16949:2016 standard set by the International Automotive Task Force (IATF). Replacing ISO/TS 16949, the IATF 16949:2016 standard aims to establish a QMS that facilitates continuous improvement, prevents defect, and helps reduce waste in the automotive supply chain.
A Standard Operating Procedure (SOP) is a standardized process that outlines a set of detailed instructions to help workers perform complex tasks properly and safely. The main objective of SOPs is to develop an effective quality system, reduce work variations and comply with industry-specific regulations and standards. Failure to follow SOPs can cause significant errors in production and operations.
Project Audit Templates
A project audit is an assessment of a project’s status against predefined success criteria and helps uncover issues and opportunities for existing and future projects. It is commonly performed for complex projects involving building & construction, engineering & design, IT & software development and organizational restructuring. It is performed by project managers or external auditors and often involves extensive interviews with project team members and stakeholders.
Layered Process Audit
Layered Process Auditing (LPA) is a quality management system in manufacturing that is designed to add layers of protection against critical risks that can lead to rework, customer complaints, costly product recalls, and damage to the company’s reputation. In an LPA, different “layers” of auditors are assigned the exact same set of audits to ensure that high-risk steps in production do not deviate from set specifications.
Factory Audit Checklist
A factory audit is a standardized process used by quality managers to determine if a supplier or vendor conforms with the required business standards in delivering high quality products and services. Performing regular factory audits involves the evaluation of a supplier’s Quality Management System (QMS), organization, production processes and compliance with safety measures.
Compliance Audit Checklists
A compliance audit is a systematic review of an organization’s adherence to predefined benchmarks set by a governing body. Compliance audits are performed by an auditing team to help the organization standardize processes, identify organizational gaps, and mitigate risks.
TACCP (Threat Assessment Critical Control Points) is a management process that aims to protect food products from deliberate contamination that is intended to cause harm. Also called food defense, TACCP helps proactively identify and manage control points in the supply chain that can be at risk of intentional contamination.
VACCP (Vulnerability Assessment Critical Control Points) is a systematic method to proactively identify and control food production vulnerabilities that can lead to food fraud. Food fraud is the deliberate “substitution, addition, tampering, or misrepresentation of food, food ingredients, or food packaging” for economic gain. VACCP aims to help protect businesses from the risk of food fraud that can cause serious food safety incidents, costly product recalls, business closure, and legal action.
A HACCP (Hazard Analysis and Critical Control Points) plan is a food safety monitoring system that is used to identify and control biological, chemical, and physical hazards within the storage, transportation, use, preparation, and sale of perishable goods. It also determines critical control points (CCP) in the process of food production. Create a HACCP plan to mitigate risks of food contamination and avoid legal issues caused by foodborne illnesses.
Supplier Audit Checklists
A supplier audit is a formalized system of evaluating the reliability and competency of suppliers and vendors to deliver a quality service. It is foundational in establishing a strong customer-supplier relationship. The supplier auditing process aims to assess and promote the smooth operation in key business areas such as manufacturing, engineering, invoicing, QA, and shipping.
FDA Inspection Templates
The US Food and Drug Administration (FDA) inspects regulated facilities to ensure their compliance with the laws and good manufacturing practice regulations surrounding the manufacture, labeling, and handling of food, drugs, medical devices, and cosmetics that are commercially distributed in the US. FDA inspections are conducted on both local and foreign establishments as long as the products are intended for US distribution. Also, new drugs and biologics require FDA approval before they are introduced to the US market.
Quality Audit Templates
A quality audit is a systematic evaluation of products and services as well as business processes and systems used for production. It helps ensure that current quality is at par with set standards. A quality audit helps in the implementation of a sound quality management system (GMS) and in meeting ISO 9001 requirements.
Dock Audit Templates
A dock audit is a quick, final inspection of finished products before they are sealed, boxed, and approved for shipping. It is a visual inspection typically performed by quality control inspectors on the shipping dock of a warehouse shortly before the product is loaded onto a freight truck for delivery. Dock audits are primarily done to catch defective and non-compliant products before they are shipped. This helps manufacturers avoid customer complaints, maintain a good business reputation, and encourage a culture of consistent, high-quality work. There is no regulating body that controls the frequency of dock audits and manufacturers can decide to perform them as often as they see fit.
A check sheet is a quality tool commonly used in the manufacturing industry to identify defects by type, location, or cause and analyze recorded data for improving the production process. As a data collection tool, check sheets enable frontline workers to capture and compile data in a consistent manner, interpret results as soon as they are collected, and observe trends from accurate data collected over time.
OEE Report Templates
An Overall Equipment Effectiveness (OEE) Report details the availability, performance, and quality of output of a given piece of equipment and its corresponding production process. Manufacturers use the OEE report as a diagnostic tool for locating the source of inefficiencies in their operations. Quality managers should report overall equipment effectiveness on a regular basis to gain insight on process improvement and boost manufacturing productivity.
Corrective Action Request Forms
A corrective action request is a formal notification sent to the supplier for rectifications to be done on a nonconforming item, process, or service. Suppliers respond to a corrective action request to report the root cause of a nonconformity and the applied corrective actions to prevent recurrence.
Visual Inspection Checklists
Visual Inspection is a method of checking the overall visual appearance or localized visual defects of a product using the naked eye. Safety and quality assurance personnel across different industries perform visual inspections to comply with safety regulations and quality standards. In manufacturing facilities, regular visual inspections ensure conformance with product design requirements and increase customer satisfaction.
Incoming Inspection Checklists
An incoming inspection, also known as a receiving inspection or material inspection, validates the quality of purchased raw materials based on set acceptance criteria. It is performed by quality assurance personnel in the manufacturing facility to resolve quality issues during pre-production. Incoming inspection results follow an identification tagging system to determine required actions when an item is tagged as accepted, conditionally accepted, or rejected.
A Pre-delivery Inspection (PDI) ensures that a newly bought vehicle is ready for the road and safe to drive before handing it over to the customer. It is usually performed at the dealership, where inspectors check every aspect of the vehicle such as the fuel and exhaust system, engine compartment, and electrical controls. PDIs also include a road test to ensure general steering and handling, transmission, and brake operation are in good working condition.
Factory Acceptance Test
A Factory Acceptance Test (FAT) is used to verify that newly produced equipment works according to its construction code and purchase order specifications. It is performed by quality managers, design engineers, operators, and maintenance personnel in the manufacturing facility before delivery and installation at the clients’ site.
Failure Mode and Effects Analysis (FMEA) is a systematic method of anticipating potential failures in business processes and mitigating their impact on customers. An FMEA template is used by product design or process improvement teams to determine the risk priority number (RPN) of the mechanism of failure and monitor the corrective actions delegated to key personnel.
CAPA Report Templates
A CAPA (Corrective and Preventive Action) Report is a tool used in identifying, addressing, and preventing regulatory and organizational non-conformance. Compliance officers record the details of an issue or incident on a CAPA Report form, which primarily includes a summary of the event, date of occurence, items and people involved, corrective actions taken, and preventive action established to avoid future recurrence.
A non-conformance report (NCR) is a document commonly used in construction industries to document work that has not met required quality standards. These reports are an essential part of the quality control process and aim to mitigate risks by implementing corrective actions and to prevent similar situations from recurring.
Retail Store Audit Checklists
Retail store audit checklists are tools that can be used to effectively control and monitor the status, branding, processes, and standardization of retail outlets. Retail store audit checklists can be used by store managers or auditors to evaluate the effectiveness of store displays, keep track of product inventory, observe store employees, and ensure the cleanliness and safety of the retail store.
Call Monitoring Forms
Call monitoring, also called agent monitoring or call logging, is the process conducted by call center managers to evaluate agent interactions with the customers. Subjected to quality assurance tests, live or recorded calls are evaluated with or without the agent’s knowledge to audit performance and improve the quality of calls.
Customer Satisfaction Survey
Customer satisfaction surveys are useful tools to measure engagement with a product or service offering. These are commonly used by retail businesses such as shops, hotels and restaurants to identify areas of improvement and maintain customer retention. An alternative to traditional online surveys and paper forms to capture customer satisfaction results is using digital kiosks. Having customers fill out feedback via an onsite digital kiosk can help you capture relevant and timely feedback.
Mystery Shopper Checklists
A mystery shopper checklist is a tool used by secret shoppers to assess and record customer experience feedback. It is a method used by companies or organizations for internal or competitive market research purposes. A mystery shopper checklist evaluates retail stores, hotels, and restaurants on areas such as customer service, cleanliness, product quality, overall layout of the establishment, safety, and many others to ensure compliance with regulations or service guidelines.
Restaurant Audit Checklists
Restaurant audit checklists can help inspectors assess if establishments are aligned with the set standards for food safety and hygiene, housekeeping, and facility maintenance. Business owners, auditors, and quality assurance teams can use these restaurant audit templates to benchmark performance, identify and address issues and assign appropriate actions.
iAuditor, the world’s #1 mobile inspection app, can help you improve your quality and safety numbers by streamlining your quality audits via hassle-free inspections, seamless data collection, and offline usability. Here are some of the best quality audit templates to get your started.